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Methylphenidate HCl Extended-Release Tablets is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate HCl Extended-Release Tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate HCl Extended-Release Tablets may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
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SUMMARY
Methylphenidate HCl Extended-Release Tablets is a central nervous system (CNS) stimulant.
Methylphenidate HCl Extended-Release Tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies].
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program
Methylphenidate HCl Extended-Release Tablets is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.
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NEWS HIGHLIGHTS
Published Studies Related to Methylphenidate
The Effect of Methylphenidate on Fatigue in Advanced Cancer: An Aggregated N-of-1
Trial. [2015]
advanced cancer... CONCLUSION: MPH does not improve fatigue in the population of patients with
Drug-specific laterality effects on frontal lobe activation of atomoxetine and
methylphenidate in attention deficit hyperactivity disorder boys during working
memory. [2014]
CONCLUSIONS: The study shows both shared and drug-specific effects. ATX
Long-term (1 year) safety and efficacy of methylphenidate modified-release
long-acting formulation (MPH-LA) in adults with attention-deficit hyperactivity
disorder: a 26-week, flexible-dose, open-label extension to a 40-week,
double-blind, randomised, placebo-controlled core study. [2014]
26-week, open-label extension phase of the same study (NCT01338818)... CONCLUSIONS: In adult patients with ADHD, use of MPH-LA up to 1 year continued to
Effect of extended-release dexmethylphenidate and mixed amphetamine salts on
sleep: a double-blind, randomized, crossover study in youth with
attention-deficit hyperactivity disorder. [2014]
measures of sleep... CONCLUSIONS: Higher stimulant doses were associated with reduced sleep duration
A randomized, double-blind, placebo-controlled, parallel-group study to evaluate
the efficacy and safety of osmotic-controlled release oral delivery system
methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in
Japan. [2014]
attention-deficit/hyperactivity disorder (ADHD)... CONCLUSIONS: OROS MPH in a dose range of 18-72 mg once daily was effective and
Clinical Trials Related to Methylphenidate
Methylphenidate Study in Breast or Gastrointestinal Cancer Patients [Terminated]
The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl
(Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma,
myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have
completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug
will also be studied. Another goal of the study is to see how certain cytokines change
while patients undergo chemotherapy or hormonal treatment.
The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease. [Terminated]
This project aims to determine if methylphenidate can improve deficits in attention and
symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with
Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on
postural control in these patients, a debilitating motor symptom that places patients at an
increased risk of falling. This study will build on existing data to support a new
indication for the use of methylphenidate in Parkinson's Disease. Using standard and
objective evaluations, this study will quantify the effect of methylphenidate at two doses
on attention levels, orthostatic hypotension, and measures of postural control. Phase I of
the study will compare methylphenidate 10mg three times daily to placebo and Phase II of the
study, for those tolerating the lower dose in Phase I, will compare methylphenidate 20mg
three times daily to placebo. By incorporating two different doses, the study also seeks to
determine if any improvements are dose-related. Secondary endpoints will include safety
assessments (adverse event monitoring and vital signs) performed every 30 minutes following
supervised drug administration. Visual analog scales will be presented to each participant
before treatment and following the final dose of each treatment to assess changes in
fatigue. A secondary task will be added to postural tests to assess the influence of
cognitive processes. It is hypothesized that methylphenidate will demonstrate a significant
beneficial effect on all outcomes. It is projected that objective improvements will be
observed following treatment with methylphenidate at both doses (10 and 20mg three time
daily) when compared to placebo. It is further hypothesized that the effects will be
dose-related and therefore more profound with higher doses.
Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate [Recruiting]
The goal of this clinical research study is to evaluate the effectiveness of ritalin
(methylphenidate) taken on an as needed basis for the management of cancer related fatigue.
The effects of methylphenidate on pain, mood, and sedation will be evaluated. Researchers
will also evaluate the level of fatigue throughout the day and any possible causes of
fatigue.
Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD) [Completed]
The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate
in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.
Effect of Methylphenidate on Connectivity [Withdrawn]
The goal of the study is to use graph theory to examine how the organization of the
functional brain network may be altered by the administration of methylphenidate. This
effect is to be compared between methylphenidate intake and placebo intake, as well as
between healthy adult males and adult males with a diagnosis of Attention Deficit
Hyperactivity Disorder.
Reports of Suspected Methylphenidate Side Effects
Completed Suicide (26),
Toxicity TO Various Agents (17),
Drug Ineffective (15),
Death (12),
Product Substitution Issue (11),
Agitation (10),
Anxiety (10),
Tachycardia (9),
Drug Abuse (8),
Decreased Appetite (7), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Methylphenidate has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Methylphenidate review by 45 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Adult ADD |
| Dosage & duration: | | 20 mg qid taken qid for the period of 5 years- still |
| Other conditions: | | anxiety, depression |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Changed my life- for the better |
| Side effects: | | Skin picking (at hands) when peak dosage declines |
| Comments: | | To treat adult ADD. Alleviated many elements of anger/depresion that had been present since childhood. Completely eradicated a 10 year cocaine habit (cocaine used to get through the day, get tasks accomplished). Never used cocaine again. Ended 20 years of heavy social drinking. |
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Page last updated: 2015-08-10
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